Sprycel

RSS

dasatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Sprycel is a cancer medicine. It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):

  • chronic myeloid leukaemia (CML) in the ‘chronic’ phase in newly diagnosed patients who are ‘Philadelphia chromosome positive’ (Ph+). In CML, granulocytes (a type of white blood cell) start growing out of control. Ph+ means that some of the patient’s genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia.
  • CML in ‘chronic’, ‘accelerated’ and ‘blast’ phases. Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;
  • Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast’ CML. Sprycel is used when other treatments do not work or cause troublesome side effects.

Sprycel is also used in children to treat:

  • newly diagnosed Ph+ CML in the ‘chronic’ phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;
  • newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).

Sprycel contains the active substance dasatinib.

This EPAR was last updated on 28/08/2019

Authorisation details

Product details
Name
Sprycel
Agency product number
EMEA/H/C/000709
Active substance
dasatinib
International non-proprietary name (INN) or common name
dasatinib
Therapeutic area (MeSH)
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Anatomical therapeutic chemical (ATC) code
L01XE06
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
33
Date of issue of marketing authorisation valid throughout the European Union
20/11/2006
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

27/06/2019 Sprycel - EMEA/H/C/000709 - II/0064

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Sprycel is indicated for the treatment of paediatric patients with:

  • newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib.
  • newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.

Sprycel is indicated for the treatment of adult patients with:

  • newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase;
  • chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate;
  • Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

Sprycel is indicated for the treatment of paediatric patients with:

  • newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
3 ratings